Qualitest Pharmaceuticals & Tardive Dyskinesia

Headquartered in Huntsville, Alabama, Qualitest Pharmaceuticals was founded in 1983 as a generic pharmaceuticals provider. Qualitest Pharmaceuticals employs about 600 individuals in a variety of positions, from research and development scientists to those who work on the plant’s production line. The company’s manufacturing facilities consists of four locations – three in Huntsville and one in Charlotte, N.C.

Qualitest Pharmaceuticals manufactures both prescription and over-the-counter medications including capsules, tablets, liquids, suspensions, creams, and ointments.

Qualitest Pharmaceuticals and Metoclopramide

Qualitest manufactures a generic metoclopramide, most commonly recognized in the U.S. by its brand name, Reglan®. Metoclopramide is usually prescribed for:

Post-surgery patients who experience nausea and vomiting caused by anesthesia.
Cancer patients who experience nausea and vomiting as a side effect of chemotherapy.
Migraine sufferers who experience nausea with their headaches.

The drug is also a prokinetic, facilitating the passing of food from the stomach to the intestines in those who have diseases like diabetic gastroparesis or gastric reflux disease. It is also commonly prescribed for heartburn.

Metoclopramide and Tardive Dyskinesia

In 2004, a study was released which indicated that the drug metoclopramide, which has been widely-prescribed throughout the U.S. since the 1980s, is responsible for the development of tardive dyskinesia when used for long-term treatment of ailments like heartburn. Tardive dyskinesia is characterized by involuntary, rapid and repetitive body movements including repeatedly sticking out the tongue, eye blinking, grimacing, other facial tics, and also spasms of the arms and legs.

While it is recommended that metoclopramide be used for 90 days, patients were prescribed a prolonged length of treatment with the drug, causing those individuals to experience permanent side effects with the onset of the movement disorder, known as TD.

When considering the risks addressed by the 2004 study, the FDA waited five years to add a black box warning on all metoclopramide packaging in 2009. As a result, many had been taking the drug without any awareness of this potentially serious side effect.

In an effort to help patients and their families better understand tardive dyskinesia, Tardivedyskinesia.com is now offering a free informational packet. To receive your packet in the mail, please enter your information below.

Sources:

http://www.qualitestrx.com/
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a684035.html
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm149533.htm
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4167B1_02_11-FDA-Tab11-Review.pdf